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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035346
Receipt No. R000040230
Scientific Title Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients
Date of disclosure of the study information 2018/12/22
Last modified on 2018/12/22

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Basic information
Public title Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients
Acronym Epidemiological characteristics of respiratory infection caused by atypical pathogens
Scientific Title Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients
Scientific Title:Acronym Epidemiological characteristics of respiratory infection caused by atypical pathogens
Region
Japan

Condition
Condition Respiratory tract infection/atypical pathogen/Mycoplasma pneumoniae/Chlamydophila pneumoniae/Bordetella pertussis/Bordetella paraperutussis
Classification by specialty
Medicine in general Pneumology Infectious disease
Pediatrics Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the epidemiological and clinical characteristics of respiratory tract infection caused by atypical pathogens in primary care patients.
Basic objectives2 Others
Basic objectives -Others The other objectives of this study are: 1) to examine the reliability of disease probabilities for atypical pathogen infection assessed by the treating physicians, referring to the results of molecular examinations; 2) to compare the antimicrobial prescription patterns among patients with positive and negative test results for atypical pathogens; 3) to compare the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutations; 4) to evaluate the utility of the Heckerling clinical decision rule for the diagnosis of pneumonia. This study further attempts to detect the pathogens of respiratory tract infection, analyzing the frozen residual samples with the automated molecular examination equipment.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The epidemiological characteristics of respiratory tract infection caused by atypical pathogens (Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydophila psittasi, Bordetella pertussis, Bordetella parapertussis).
Key secondary outcomes 1) The sensitivity, specificity, positive/negative predictive value, and odds ratio of the clinical signs and symptoms for the diagnosis of respiratory infection caused by different atypical pathogens.
2) The agreement between the clinical disease probabilities of atypical pathogen infection assessed by the treating physicians and the results of molecular examinations.
3) The changes in the reliability of disease probabilities assessed by the treating physicians during the study period.
4) The differences in the antimicrobial prescription patterns between patients with positive and negative test results for atypical pathogens.
5) The differences in the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutation.
6) The sensitivity, specificity, positive/negative predictive value and odds ratio of the Heckerling clinical decision rule for the diagnosis of community-acquired pneumonia.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are eligible for this study if all of the following criteria are met:
1) Patients are able to provide written informed consent
2) Patients have both fever (one degree higher than normal body temperature or body temperature > 37 degrees Celsius) and cough, one of which persists at least three days
3) Patients are treated by the study investigators
Key exclusion criteria Patients are excluded if one of the following criteria is met.
1) Patients or proxies are unable to provide informed consent in Japanese
2) Patients have severe conditions (e.g., altered mental status and shock state), and sample collections are unable to be performed safely
3) Patients have chronic lung disease with multiple episodes of acute exacerbation
4) Patients have clinically evident sinusitis or tonsillitis with tonsillar exudate and swelling
5) Patients have lung tuberculosis, lung mycosis, or nontuberculous mycobacterial lung disease
6) Patients are diagnosed with hospital-acquired pneumonia or healthcare-associated pneumonia
7) Patients have dysphagia or a history of aspiration
8) Patients have obstructive pneumonia, empyema, or lung abscess
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromichi Suzuki
Organization Tsukuba Medical Center Hospital
Division name Division of Infectious Diseases, Department of Medicine
Zip code
Address 1-3-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL 029-851-3511
Email hsuzuki@tmch.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromichi Suzuki
Organization Tsukuba Medical Center Hospital
Division name Division of Infectious Diseases, Department of Medicine
Zip code
Address 1-3-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL 029-851-3511
Homepage URL
Email hsuzuki@tmch.or.jp

Sponsor
Institute Tsukuba Medical Center Hospital
Institute
Department

Funding Source
Organization Toyobo
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (Variables)
#Demographic data
Age, sex, residential status, the epidemic data of atypical pathogen infection in local communities where patients come from, close contact with cases with atypical pathogen infection, comorbidities, the history of influenza vaccination, the number of visits to hospitals/clinics, the prescribed antibiotics before examinations, smoking history

#Signs and symptoms
The progression of illness, fever, cough, sputum production, nasal obstruction, myalgia, arthralgia, headache, fatigue, chill, feverish sensation, diarrhea, vomiting

#Physical examination
Blood pressure, respiratory rate, pulse rate, body temperature, saturation of peripheral oxygen, consciousness, tonsillar swelling, tonsillar exudate, pharyngeal erythema, cervical lymphadenopathy, skin rash, an abnormal respiratory sound on chest auscultation

#Laboratory findings
Plain chest radiography, chest computed tomography, white blood cell and differential, C-reactive protein, lactate dehydrogenase, blood urea nitrogen, the results of molecular examinations*
* GENECUBE Mycoplasma, GENECUBE Chlamydia pneumoniae and GENECUBE Bordetella pertussis are used for the analysis of fresh nasopharyngeal or pharyngeal samples to detect atypical pathogens. As an additional analysis, BIOFIRE FILMARRAY multiplex PCR system and Respiratory Panel are used to identify causative pathogens of respiratory infection using frozen residual samples. Regarding the analysis of macrolide resistance, GENECUBE Mycoplasma is employed for M. pneumoiniae and BIOFIRE FILMARRAY multiplex PCR system and Respiratory Panel are applied for other pathogens.

#Others
The duration from the symptom onset to examinations, the disease probabilities of atypical pathogen infection assessed by the treating physicians, the prescribed antibiotics, a contact of swab with the posterior pharyngeal wall or the nasopharyngeal wall during sample collection, the extent of visible area in pharynx during a pharyngeal inspection

Management information
Registered date
2018 Year 12 Month 22 Day
Last modified on
2018 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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